COVID-19 Records

March 24, 2015 - Same political issues regarding the potential NIH RCT in Guinea.

Diary Prequel Package, p.436 · diary_prequel:entry:01174

Page text: p.436 · original PDF

Date
2015-03-24 00:00 (day precision)
Type
diary entry · diary
author
Anthony S. Fauci
Topics
Vaccines
March 24, 2015 - Same political issues regarding the potential NIH RCT in Guinea. Kai Kupferschmidt from Nature wanting to do a story about "rivalry among scientists. Like the Peter Duesberg situation decades ago, they are "equating" us with Marie-Paul Kieny of WHO. I cannot say to Kai, but Marie-Paul is an idiot. Had long 3-way conversation over the phone: Kai who just flew in from berlin for the Filovirus Meeting in DC tomorrow is connected from his hotel here in DC; Cliff from his home and me from my home (10:00 PM). We try to explain to Kai that we are not trying to interfere with the "Ring" trial; we just want to get the correct answer for the good of all of West Africa. He keeps pushing that they started off with Guinea and now that Liberia has few/no infections, we want to go to Guinea and "ruin" their study. Nonsense. You can do 2 studies simultaneously in as large a country as Guinea. Besides, ring vaccination is not a study; it is vaccine distribution of an unproven vaccine.

Extracted statements

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StatementGradeAttributionStance
Besides, ring vaccination is not a study; it is vaccine distribution of an unproven vaccine. own voice, substantive speaker_own asserts

In context

A single line often inverts meaning once you see what it answers, so neighbouring messages are always shown.

  1. 2015-03-20 00:00 Anthony S. Fauci open
    March 20, 2015 - Patient stable this AM. First day of Spring today and we have snow in DC. What a winter - Ugh! Went in again today to go over patient with Dan Chertow. In for about 65 minutes. Making morning (8:00 AM) and evening (6:30 PM) report now every day with the Unit staff.
  2. 2015-03-21 00:00 Anthony S. Fauci open
    March 21, 2015 - Good news. Creatinine stabilized for 3 determinations in a row at around 6 with BUN at around 115. We may get away without having to dialyze. Main problem now is meningoencephalitis. Avi Nath (NINDS- neurologist) helping out with neuron-management. He can only do so by history and video since he is not trained to enter room. We cannot fully evaluate this until we lighten up his sedation, given what happened the other night, we will do this very slowly. We have started low dose heparin now that his platelets are coming up. CT (Cycle threshold) is now 34.5! All we need to do is avoid PEs and bleeding. More later. Now the Norwegians and to some extent the Canadians (much less so) are getting upset with us since we are working with the Guineans via INSERM (Delfraissy/Levy) and the interaction between the Liberians and Guineans to expand the vaccine RCT to Guinea, where there are still cases. The Norwegians are trying to do a "Ring Vaccination" study around cases similar to what was done with smallpox. However, the smallpox situation was using a proven, highly effective vaccine. You do not "test" a vaccine in a ring "study". The Norwegians are concerned that our introduction of an RCT where they are doing a Ring study would be a problem. I can understand what their concern is; however, the elephant in the room is the fact that there study is not a study. It is a "distribution" of an unproven product. This is the same European mentality that just because this is a serious disease, then there is no room for research; just distribute what you have. This same mentality led to Guinea adopting Favipiravir as standard of care based on an open access study that claimed benefit; however, when the data was presented at the CROI meeting, it was clear that there was no indication of efficacy since the outbreak incidence was shifting during the study and historical controls were not valid. God bless Cliff for sticking to his guns about RCT and good science. In this regard, my old friend Tore Godal from Norway e-mailed me with concern about our study since he is one of the Norwegians who are pushing the Ring study. Of note, in their communications, nowhere are there any Guineans. Sounds like the old paternalism.
  3. 2015-03-22 00:00 Anthony S. Fauci open
    March 22, 2015 (Sunday)- Spent all of the day at NIH and hours in the SCSU in with patient and doing AM and PM rounds. Danny Jaswal was the ICU attending and Tuan was the ID person. Avi Nath did neuro exam and actually wwent into the room after getting trained in PPE
  4. 2015-03-23 00:00 Anthony S. Fauci open
    March 23, 2015 - . I have some good news. His renal function continues to improve with a creatinine today of 3.6. He is in the polyuric phase of ATN with a urine output after stopping Lasix over the past 24 hours of >100 cc/hr. His LFTs have normalized. His cardiopulmonary function is good. On neuro exam today, his boardlike stiff neck can now bend by 45 degrees and his sustained clonus is now down to 5 beats. We had our ophthalmologist (Rachel Bishop) examine him today with a neat gadget hooked onto a cell phone, which together with a hand lens gave us a good look at his retina. Good news is that he has no papilledema and no evidence of clinically significant uveitis. Tomorrow morning we will attempt to stop his ketamine and fentanyl and gradually taper off his propofol. If he wakes up without being combative and is stable for a period of time, we will consider pulling his endotracheal tube. His CT is 37 and so he is almost cleared of virus from his blood. Fingers crossed. magazine as one of the world's 50 it for voting "100 of the world's most Paul Farmer called my cell phone as I was getting ready to do today and I gave him a summary of progress. Having "political issues" with the Norwegians getting upset that Cliff and I want to extend our RCT vaccine trial to Guinea since they are doing the ring vaccination there. See my comments above.
  5. 2015-03-24 00:00 Anthony S. Fauci
    March 24, 2015 - Same political issues regarding the potential NIH RCT in Guinea. Kai Kupferschmidt from Nature wanting to do a story about "rivalry among scientists. Like the Peter Duesberg situation decades ago, they are "equating" us with Marie-Paul Kieny of WHO. I cannot say to Kai, but Marie-Paul is an idiot. Had long 3-way conversation over the phone: Kai who just flew in from berlin for the Filovirus Meeting in DC tomorrow is connected from his hotel here in DC; Cliff from his home and me from my home (10:00 PM). We try to explain to Kai that we are not trying to interfere with the "Ring" trial; we just want to get the correct answer for the good of all of West Africa. He keeps pushing that they started off with Guinea and now that Liberia has few/no infections, we want to go to Guinea and "ruin" their study. Nonsense. You can do 2 studies simultaneously in as large a country as Guinea. Besides, ring vaccination is not a study; it is vaccine distribution of an unproven vaccine.
  6. 2015-03-25 00:00 Anthony S. Fauci open
    March 25, 2015 - Good news at SCSU: We extubated uneventfully! Went in to see him and he is emotionally very grateful for what our team did for him. Paul Farmer came up from Haiti to visit as well as the other PIH personnel (contacts to who are "nested" in the Maryland area for observation in case they develop sxs. Organ system function markedly improving. Creatinine 1.4!! Still some muscle weakness. Will leave urinary catheter in tonight and keep him NPO since his voice is very weak and his trachea is irritated. CT is 39+; however, his CT of his trachea aspirate is 26. Could there be sequestration of virus in tracheal secretions or is this just accumulation of dead virus Kai (above) is still agitating with questions to Cliff about our upsetting the Norwegian study. Met with Morgan Fairchild in my office today at 3:30 PM to discuss what NIAID could do for Chronic Fatigue Syndrome, now re-named Severe Exertion Intolerance Disease (SEID). Will give talk tomorrow at the Filovirus Meeting in DC and so will miss Harold Varmus's last IC Director meeting. Said goodbye to him and Connie today. I will miss him greatly.
  7. 2015-03-26 00:00 Anthony S. Fauci open
    March 26, 2015 - I have been chosen by Fortune magazine as one of the world's 50 greatest leaders. Also, I am on Time magazine list for voting "100 of the world's most influential people" Patient doing well. Gave talk at the 7th International Filovirus Meeting at Marriott Hotel at Metro Center run by Heinz Feldmann. Talk went over very well. Kai Kupferschmidt was in audience and was blown away when I showed slides of me in PPE taking care of He came over afterwards and is writing a short online blog on how incredible it is that a director of a large research institute who is 74 years old is taking care of an Ebola patient. Spent a full hour with in the SCSU. He is now very talkative; however, he does have a slight expressive aphasia. His strength is coming back and he is taking a soft diet (apple sauce, etc.). Creatinine now 1.2. CT around 39. May still have some virus in tracheal secretions. He has an occasional cough that is dry; may be slightly aspirating due to pharyngeal muscle weakness. Paul Farmer heading out tomorrow to go back to West Africa via Boston.
  8. 2015-03-27 00:00 Anthony S. Fauci open
    March 27, 2015 - Today was a very interesting day. The patient is wide-awake all of his chemistry numbers are normal. I spent a full hour in the room with him speaking with him about a variety of subjects. He clearly is in somewhat of a hypomanic state. He continually speaks and in a pressured manner. We now know that he has a depressive disorder on meds and this hypomanic state could be a combination of our inadvertently taking him off his psychotropic meds (although his ketamine, etc.) would substitute for that) and his developing a manic phase to his underlying depression as a result of the amazing stress of his illness. As far as his organ system function goes he is doing very well except for some residual weakness and conjunctivitis in his right eye. We hope that this is not Ebola uveitis. He will be seen by ophthalmology tomorrow. Cliff Lane and I had a very disturbing conversation today with Yves Levy (President of INSERM) who is in Paris. It is becoming very clear that Marie-Paule Kieny (WHO) for political reasons in order to show that the World Health Organization was doing something for Ebola has been pushing a ring vaccination trial in Guinea together with the Norwegians. Cliff and I (mostly the hard work of Cliff) are working with the Guineans to expand our Liberian RCT vaccine trial to Guinea where there are still infections going on. WHO and the Norwegians do not want us to start the RCT in Guinea and are leaking to the press that we are trying to "derail" their trial. In fact, the Norwegian government has complained to our State department about our trying to start the RCT in Guinea. The French (Levy and Delfraissy) agree with Cliff and I that the ring vaccination in Guineas will not be able to determine efficacy. Of note, both Levy and Delfraissy are on the scientific advisory board for that trial even though they do not believe that it is scientifically sound. I gently chastised Yves on the phone telling him that he should resign from the board. Bottom line is that he told Cliff and me that this is politically sensitive since Marie-Paule is pushing the ring trial purely for "political reasons" in trying to show that WHO is "doing something and leading something". For some inexplicable reason, she has gotten the Norwegians (John-Arne...) to buy into this. Yves knows as do Cliff and I that Marie-Paule is close to being incompetent and knows nothing about the research method of clinical trials. First, there should not be a ring vaccination since ring approach assumes that the vaccine works. We are trying to determine scientifically if it works. Everyone knows that an RCT is the "gold standard" to determine safety and efficacy. We are convinced that the Guineans would go along with the best scientific approach. Yet, WHO is trying to block the initiation of our trial until they have finished their trial that everyone with any sense knows that the ring trial will be inadequate. This is "politics" at its worst. Marie-Paule should really be fired. If we were the type to leak this to the press such as to Jon Cohen or Kai Kupferschmidt from Science, this would be a scandal for WHO. Finally, in the arena of incompetence and politics, the "Favipiravir study" in Guinea done by MSF and the French is claiming to show that it works (see above) even though there is no control group except an "historical control". Now the French are telling us that the Guineas are making Favi part of their standard of care (SOC). Thus, is we want to extend out ZMapp study to Guinea (where there are infections), then we would not be able to compare SOV versus SOC + ZMapp as we are doing in the USA and Liberia, and now Sierra Leone. The FDA and we feel that FAVI should not be SOC and if fact might be harmful. We will try to work with the health and political types in Guinea to get a proper ZMapp study going. Truly amazing politics, ignorance, and LACK of INTEGRITY on the part of people including people in WHO. MSF just does not know much about doing clinical research, even though they are "heroes" for their clinical care work.
  9. 2015-03-28 00:00 Anthony S. Fauci open
    March 28, 2015 - Unusually cold, clear day for Spring in Bethesda. Around 28 in the AM. Patient continues to do well. Still hypomanic and not getting any sleep. We are reluctant to medicate him too much due to concern about prolonged QTC. Cliff and I continued our conversation by phone with Yves Levy in Paris and us in Cliff's conference Room on the 4th Floor of the ACRF in Building 10. Yves now agrees with everything that I indicated in note from March 27 (above). He will work to help get the RCT done in Guinea and we will work together with the RCT therapy trial in that the French will try to do the SOC + FAVI Versus SOC+FAVI+ZMAPP and we will do SOC versusSOC + ZMapp.

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